Full Press Release Details
Announces 2020 Financial and Operational Results
Total Revenue was $41.0 million, with 2020 Product Sales of $39.5 million, up 73% over 2019. Achieved record Product Gross Margins
JUNCTION, N.J., March 9, 2021 - CytoSorbents Corporation (NASDAQ: CTSO) a critical care immunotherapy leader
commercializing its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac
surgery patients around the world, achieves record Total Revenue and CytoSorb sales in 2020, and record Product Gross Margins
Financial Highlights:
Operating Highlights:
Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "In our recent stockholder letter, I discussed
how the company successfully navigated a challenging 2020 and outlined our expectation for continued growth this year as we eventually
transition from COVID-19 to the new normal.' I would encourage you to read the letter if you have not already done
addition to our business objectives, we are focused on executing our clinical plan to support regulatory approvals, inclusion
into standard treatment guidelines, and reimbursement. Our emphasis is to conduct rigorous, adequately powered, multi-center,
company sponsored clinical trials. To this end, we have significantly expanded our clinical trial operational capabilities and
will continue to do so in 2021."
first priority is to leverage our Breakthrough Designation to remove ticagrelor (Brilinta ; AstraZeneca) during urgent
or emergent cardiothoracic surgery, and to implement our clinical and regulatory strategy to gain U.S. approval. We believe this
is the most expeditious, lowest risk, and least burdensome path to U.S. regulatory approval that leverages our extensive cardiac
surgery experience, good clinical outcomes, and regulatory approvals in Europe in this application, from which we can then build
our critical care and cardiac surgery franchises in the future. Following productive prior discussions with the FDA, we expect
to imminently file an investigational device exemption (IDE) application to conduct a well-designed and powered clinical trial
in the U.S. to demonstrate the clinical benefit of our therapy. This STAR-T Trial (Safe and Timely Antithrombotic
Removal of Ticagrelor) will be led by two world-renowned Principal Co-investigators, with support from a distinguished
Executive Committee. We have already screened and obtained the commitment from the majority of needed U.S. centers to participate
in the study. In addition, the trial has been designed to obtain the clinical and health economics data needed to support a U.S.
regulatory filing for this application, and also reimbursement. As previously noted, the Centers for Medicare & Medicaid Services
announced the Medicare Coverage of Innovative Technology pathway that will provide national Medicare coverage for approved
Breakthrough Medical Devices for 4 years. We plan to work closely with the FDA to expedite the review and approval of the IDE,
and will have more detail on the final trial design at that time."
we are forging ahead with our efforts to open the U.S. market to our therapy for the removal of the direct oral anticoagulants
(DOACs) in emergent or urgent cardiothoracic surgery. These include blockbuster anticoagulant medications such as the Factor Xa
inhibitors - Eliquis (apixaban; Pfizer, Bristol Myers Squibb), Xarelto (rivaroxaban; Janssen, Bayer), and Lixiana
and Savaysa (edoxaban; Daiichi Sankyo, Daewoong Pharmaceutical), as well as the direct thrombin inhibitors such as Pradaxa
(dabigatran; Boehringer Ingelheim). As with ticagrelor, these blood thinners are also often associated with severe to life-threatening
perioperative bleeding after cardiothoracic surgery. We anticipate that the clinical and regulatory pathway will be similar to
that for ticagrelor. Our technology has shown the ability to remove all of these agents in vitro, and in the case of rivaroxaban
and apixaban, in humans during cardiac surgery. This application would target an additional total addressable market in the U.S.
alone of approximately $500M."
addition to the above, the company-sponsored CyTation trial in Germany for ticagrelor removal is open for enrollment, though the
U.K. TISORB study has been impacted by COVID-19 restrictions in that country. We have also developed the STAR registry, that will
collect real world data on the removal of antithrombotics with our blood purification technology."
are currently prioritizing the STAR-T trial. However, we plan to resume the U.S. REFRESH 2-AKI trial as soon as possible, pending
COVID-19 restrictions. In addition to the studies above, we plan to initiate multiple other company-sponsored studies this year,
including the multi-center, randomized, controlled PROCYSS (Prospective, Randomized, COntrolled
Trial To Evaluate CYtoSorb For Shock Reversal in Septic Shock) trial in refractory septic shock
in Germany anticipated to start in the third quarter, and the HepOnFire single arm pilot study in liver disease expected to start
in the fourth quarter. The results of the REMOVE endocarditis study are expected soon. Finally, we plan to submit a publication
on the results from ECMO and CytoSorb from the multi-center U.S. CTC registry and a review article summarizing the international
experience in COVID-19 patients treated with CytoSorb and CRRT or hemoperfusion."
further updates on our existing business, we invite you to join us on our earnings conference call, details below."
Tuesday March 9, 2021
4:45 PM Eastern Time
Dial-In: 1-201-389-0879
Presentation Webcast http://public.viavid.com/index.php?id=143499
is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous
live webcast of the conference call that can be accessed through the following audio feed link: http://public.viavid.com/index.php?id=143499
archived recording and written transcript of the conference call will be available under the Investor Relations section of the
Company's website at http://cytosorbents.com/investor-relations/financial-results/
Year 2020 Financial Results:
the year ended December 31, 2020, we generated total revenue, which includes product revenue and grant income, of approximately
$41,005,000 as compared to revenues of approximately $24,949,000 for the year ended December 31, 2019, an increase of approximately
$16,056,000, or 64%. Revenue from product sales was approximately $39,453,000 for the year ended December 31, 2020, as compared
to approximately $22,766,000 in the year ended December 31, 2019, an increase of approximately $16,787,000 or 73%. This increase
was driven by an increase in direct sales of approximately $8,917,000 resulting from sales to both new customers and repeat orders
from existing customers and an increase in distributor sales of approximately $7,769,000. Sales to hospitals in the United States
under the EUA granted by the FDA amounted to approximately $1,341,000 for the year ended December 31, 2020. Though difficult to
quantitate, we estimate that approximately $9.4 million of total product sales during the year ended December 31, 2020 was due
to the demand for CytoSorb to treat COVID-19 patients. In addition, as a result of the increase in the average exchange rate of
the Euro to the U.S. dollar, sales were positively impacted by approximately $693,000. For the year ended December 31, 2020, the
average exchange rate of the Euro to the U.S. dollar was $1.14 as compared to an average exchange rate of $1.12 for the year ended
the years ended December 31, 2020 and 2019, cost of revenue was approximately $11,052,000 and $7,364,000, respectively, an increase
of approximately $3,688,000. Product cost of revenues increased approximately $4,180,000 during the year ended December 31, 2020
as compared to the year ended December 31, 2019 as a result of the increase in product sales. Product gross margins were approximately
76% for the year ended December 31, 2020 and approximately 77% for the year ended December 31, 2019. The decrease in gross margin
was due to an increase in percent contribution of lower margin distributor sales as well as certain costs associated with the
rapid ramp-up of production during the year ended December 31, 2020.
profit was approximately $29,952,000 for the year ended December 31, 2020, an increase of approximately $12,366,000 or 70%, over
gross profit of $17,586,000 in 2019. This increase is attributed to an increase in CytoSorb product sales during 2020.
and Development Expenses:
research and development costs were approximately $8,811,000 and $12,092,000 for the years ended December 31, 2020 and 2019, respectively,
a decrease of approximately $3,281,000, or 27%. This decrease was due to a decrease in clinical trial and related costs of approximately
$3,769,000, due primarily to the pause in our Company-sponsored clinical trials as a result of hospital restrictions due to the
COVID-19 pandemic, and a decrease in our non-grant related research and development costs of approximately $393,000. These decreases
were offset by an increase in non-clinical research and development salary related costs of approximately $160,000 due primarily
to COVID-19 related incentive pay, decreases in direct labor and other costs being deployed toward grant-funded activities of
approximately $675,000, which had the effect of increasing the amount of our non-reimbursable research and development costs and
an increase in new product development costs of approximately $46,000.
Financial and Other Consulting Expenses:
legal, financial and other consulting costs were approximately $3,048,000 and $2,462,000 for the years ended December 31, 2020
and 2019, respectively, an increase of approximately $586,000, or 24%. This increase was due to an increase in employment agency
fees of approximately $395,000 related to the hiring of senior level personnel, an increase in consulting fees of approximately
$219,000 primarily related to certain financial advisory fees and an increase in accounting and auditing fees of approximately
$40,000. These increases were offset by a decrease in legal fees of approximately $70,000.
General and Administrative Expenses:
selling, general and administrative expenses were approximately $28,464,000 and $22,006,000 for the years ended December 31, 2020
and 2019, respectively, an increase of approximately $6,458,000, or 29%. This increase was due to an increase in salaries, commissions
and related costs of approximately $4,849,000 due primarily to headcount additions and increased commissions due to increase sales,
an increase in royalty expenses of approximately $1,327,000 due to the increase in product sales, and an increase in non-cash
stock option expense of approximately $1,879,000. These increases were offset by reductions in sales and marketing costs, which
include advertising and conference attendance of approximately $824,000 and travel and entertainment and other general and administrative
expenses of approximately $773,000. These reductions were due primarily to travel restrictions related to the COVID-19 pandemic.